Comparison of Two Routes of Administration of a Multimodal Analgesic Protocol in Postoperative Cesarean Section

C

Centre de Maternité de Monastir

Status and phase

Completed
Phase 3
Phase 2

Conditions

Postoperative Pain
Cesarean Section; Complications, Wound, Infection (Following Delivery)
Spinal Anaesthesia During the Puerperium

Treatments

Drug: Nefopam 20 MG/ML
Drug: "Acetaminophen, (paracetamol)" 500Mg Tab
Drug: (Piroxicam "piroxan") 20Mg/1mL Injection
Drug: (Piroxicam "piroxan") 20 MG Oral Tablet
Drug: "Nefopam (Acupan)" 20 MG/ML Injectable Solution
Drug: (Acetaminophen "paracetamol") IV Soln 10 MG/ML

Study type

Interventional

Funder types

Other

Identifiers

NCT03626753
CMNMonastir

Details and patient eligibility

About

Many drugs with various mechanisms of action are used for postcaesarean pain relief. Although the response to pain relief is sometimes believed to be individual, it is very important to establish the most effective with the least adverse effects type of oral analgesia for women after caesarean section. Optimal pain control post-caesarean section will benefit not only the mother and her baby, but also a healthcare system. Optimal pain control may shorten the time spent in hospital after caesarean section and, therefore, reduce healthcare costs.

Full description

Pain after cesarean section (CS), usually described as strong, is an obstacle to good mother-child interaction and post-operative rehabilitation. Its management is important for a quick recovery and allow the mother to take care and link with her newborn. Currently, intrathecal opioids are the most commonly used technique and provide the foundation for post-cesarean analgesia. This technique combined with multimodal analgesia reduces the doses of morphine consumed, including these side effects. Spinal anesthesia is the standard anesthetic technique for caesarean section; it offers several advantages including the possibility of prescribing oral analgesics. An ideal analgesic protocol is one that is simple to implement, cost-effective, and has minimal impact on the work staff. It would have a good safety profile, a low incidence of side effects and complications, and respond to wide inter-patient variability. It relieves the mother of high quality pain while having minimal interference with her, newborn care and anesthesia while allowing safe breastfeeding. The aim of this work is to compare the quality of an multimodal oral analgesia with intravenous analgesia and to demonstrate non-inferiority of the oral route pain relieve in postoperative caesarean section period. The secondary objectives was to evaluate the maternal tolerance of the drugs (piroxicam, nefopam, paracetamol) used postoperatively of a caesarean section.

Enrollment

200 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Pregnant in singleton pregnancy with gestational age \> 34 weeks * American society of anesthesiologists (ASA) physical status I-II.

Exclusion criteria

* history of gastrointestinal disorders predisposing to bleeding disorders such as ulcerative colitis, * Crohn's disease, * gastrointestinal cancers or diverticulitis, * an active peptic ulcer, * an inflammatory gastrointestinal disorder or a gastrointestinal haemorrhage, * parturients who present preeclampsia, * premature delivery (\<32 weeks), * constitutional or acquired coagulopathy, * An antecedent of hemorrhage of the delivery, * a hemorrhagic complication postoperatively, * Anemia (hemoglobin less than 8g / 100ml), * conversion of spinal anesthesia into general anesthesia, * women with severe medical conditions: renal failure (preoperative creatinine clearance \<30ml / min), heart or liver failure.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups

Oral Group
Active Comparator group
Description:
received in post operative period oral analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Treatment:
Drug: (Piroxicam "piroxan") 20 MG Oral Tablet
Drug: "Acetaminophen, (paracetamol)" 500Mg Tab
Drug: Nefopam 20 MG/ML
Intravenous group
Active Comparator group
Description:
received in post operative period intravenous analgesia ( "nefopam (Acupan)" 20mg/6h, "piroxicam (piroxan)" 40mg/24h," Acetaminophen (paracetamol)" 1g/6h)
Treatment:
Drug: (Acetaminophen "paracetamol") IV Soln 10 MG/ML
Drug: "Nefopam (Acupan)" 20 MG/ML Injectable Solution
Drug: (Piroxicam "piroxan") 20Mg/1mL Injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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